Extraluminal sealant applicator and method

ABSTRACT

An apparatus for applying sealant to a target tissue of a surgical site is provided. The apparatus includes a handle, conduit and an end effector. The handle has means configured and adapted for operating the end effector and dispensing biological sealant to the surgical site via the end effector. The conduit stores and/or carries sealant towards the end effector. The end effector is configured to clamp around a body organ or tissue and apply and confine biological sealant in a substantially uniform manner thereto.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application Ser. No. 60/620,018, filed on Oct. 18, 2004, theentire contents of which being incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical instruments and methods forenhancing properties of tissue repaired or joined by surgical staplesand, more particularly to surgical instruments and methods designed toapply and confine a non-mechanical biocompatible wound closure materialto enhance the properties of repaired or adjoined tissue at a targetsurgical site.

2. Background of Related Art

Throughout the years the medical field has utilized various techniquesin an effort to join or bond body tissue together. Historically,suturing was the accepted technique for rejoining severed tissues andclosing wounds. Suturing was historically achieved with a surgicalneedle and a suturing thread, and more recently, with a variety ofpolymeric or metallic staples, as will be discussed below. The intendedfunction of sutures is to hold the edges of a wound or tissue againstone another during the healing process so as to reduce discomfort, pain,scarring and the time required for healing.

Staples have recently been used to replace suturing when joining oranastomosing various body structures, such as, for example, the bowel orbronchus. The surgical stapling devices employed to apply these staplesare generally designed to simultaneously cut and seal an extendedsegment of tissue in a patient, thus vastly reducing the time and risksof such procedures.

Linear or annular surgical stapling devices are employed by surgeons tosequentially or simultaneously apply one or more linear rows of surgicalfasteners, e.g., staples or two-part fasteners, to body tissue for thepurpose of joining segments of body tissue together and/or for thecreation of anastomosis. Linear surgical stapling devices generallyinclude a pair of jaws or finger-like structures between which bodytissue to be joined is placed. When the surgical stapling device isactuated and/or “fired,” firing bars move longitudinally and contactstaple drive members in one of the jaws, and surgical staples are pushedthrough the body tissue and into/against an anvil in the opposite jawthereby crimping the staples closed. A knife blade may be provided tocut between the rows/lines of staples. Examples of such linear surgicalstapling devices are Models “GIA™” and “Endo GIA™” instruments availablefrom United States Surgical, a Division of Tyco Health-Care Group, LP,Norwalk, Conn. and disclosed in, inter alia, U.S. Pat. No. 5,465,896 toAllen et al., the entire contents of which is incorporated herein byreference.

Annular surgical stapling devices generally include an annular staplecartridge assembly including a plurality of annular rows of staples,typically two, an anvil assembly operatively associated with the annularcartridge assembly, and an annular blade disposed internal of the rowsof staples.

Another type of surgical stapler is an end-to-end anastomosis stapler.An example of such a device is a Model “EEA™” instrument available fromUnited States Surgical, a Division of Tyco Health-Care Group, LP,Norwalk, Conn. and disclosed in, inter alia, U.S. Pat. No. 5,392,979 toGreen et al., the entire contents of which is incorporated herein byreference. In general, an end-to-end anastomosis stapler typicallyplaces an array of staples into the approximated sections of a patient'sbowels or other tubular organs. The resulting anastomosis contains aninverted section of bowel which contains numerous “B” shaped staples tomaintain a secure connection between the approximated sections of bowel.

In addition to the use of surgical staples, sealants, e.g., biologicalsealants, can be applied to the surgical site to guard against leakage.Typically, the biological sealants are manually applied to the outersurface of the staple line by a physician by spraying on, brushing on,swabbing on, or any combinations thereof. This manual application ofbiological sealant can lead to non-uniformity of the thickness ofsealant across the staple line and/or omitting a portion of the intendedcoverage area due to inability to see or reach the desired location.

A need exists for surgical apparatus or structure for applying woundtreatment material to an exterior surface of tissue to bond tissue,guard against leakage and the like.

SUMMARY

The present disclosure relates to surgical instruments and a method forapplying an adhesive or sealant to an anastomosis site after the sitehas been surgically stapled and for confining the sealant to the desiredlocation. As used herein, sealant is intended to encompass a broad rangeof biologically compatible materials including tissue adhesive, tissuesealing compositions, etc.

The present extraluminal sealant applicator includes a handle, a shaftand an end effector, such as a clamp. The handle has means configuredand adapted for operating the end effector and dispensing biologicalsealant to the surgical site via the end effector. The shaft containsconduit therein or thereon for storing sealant and/or carrying sealanttowards the end effector. The end effector is configured to clamp arounda body organ or tissue and apply and confine biological sealant in asubstantially uniform manner thereto.

An apparatus is disclosed for applying sealing to a target tissue of asurgical site. The apparatus comprises a handle, an end effector and atleast one conduit for conveying sealant The end effector includes asealant-applying structure for applying sealant to the target tissue.The conduit conveys sealant to the sealant-applying structure in the endeffector.

In one embodiment, the end effector is in the form of a clamp, which maycomprise two jaw members.

The apparatus may also include a shaft extending between the handle andthe end effector. The shaft defines a longitudinal axis.

It is envisioned for each of the jaw members to be arcuate or planarwith respect to the longitudinal axis.

Each of the jaw members may be rigid or deformable. It is contemplatedthat one jaw member is rigid and the other jaw member is deformable.

In an embodiment, at least one of the jaw members includes at least onereservoir.

It is contemplated for at least one of the jaw members to comprise sidewalls, which confine sealant. Each side wall includes a first endoperatively connected to the jaw member and a second end extending fromthe jaw member to come into contact with tissue when the end effector isin a closed condition. At least one side wall may comprise elements forincreasing friction between the second end of the side wall and tissue.It is envisioned that the elements for increasing friction are pins. Theside walls may be rigid or flexible.

It is envisioned for the end effector to comprise a locking means formaintaining the end effector in a closed condition.

In an embodiment, the shaft comprises at least one conduit extendingtherethrough for carrying sealant from the handle to thesealant-applying structure of the end effector.

It is envisioned for the handle to comprise means for locking the endeffector in a closed condition. The handle may also include a structure,such as a sliding mechanism or a lever, for controllably operating theend effector.

The sealant-applying structure of the present disclosure may be, forexample, a lever or a sliding mechanism.

The present disclosure also includes a method for applying sealant to atarget tissue site. The method includes the steps of providing anapparatus having a clamp; positioning the clamp around and closing theclamp on the target tissue site; and applying sealant to the targettissue site via the clamp.

In one embodiment, the present disclosure includes an apparatus forapplying sealant to a target tissue site. The apparatus comprises an endeffector, side walls and a conduit. The end effector is operativelyconfigured to be able to substantially surround the target tissue site.The side walls confine sealant. The conduit is in fluid association withthe end effector and conveys sealant to the end effector for dispensingonto the target tissue site. The end effector may include two jawmembers, which may be configured to releasably lock with each other whenthe end effector is positioned around the target tissue site.

The apparatus and method of the present disclosure may be implementedafter an anastomosis procedure where a body organ, such as an intestine,bronchus or bowel, is surgically stapled using an end-to-end anastomosisstapler or other suitable device. After such a procedure, the disclosedapparatus is positioned near the staple line of the tissue, with theclamp in an open position. A user then closes the clamp around the organby using a clamping means, such as a trigger, button, sliding device,etc., which may be disposed on the handle of the apparatus. It isenvisioned for the clamping means to both close and open the clamp.After the clamp is closed, the user applies the biological sealant tothe desired clamped location by using a sealant-applying structure, suchas a trigger, button, sliding device, etc., which may be disposed on thehandle of the apparatus. Once the sealant is applied to the surgicalsite, the user of the disclosed apparatus may continue to maintain theclamp in a closed position until the sealant has sufficiently cured.After sufficient curing has taken place, the user may open the clampusing the clamping means and remove the apparatus from the patient'sbody.

The extraluminal sealant applicator may further include a locking meansdisposed on the clamp, e.g., the distal portion of the clamp, tomaintain the clamp in a closed position around the body organ or tissue.In addition, a locking means may be located on the handle of theapparatus for locking the clamp in a desired position.

The extraluminal sealant applicator of the present disclosure mayfurther include a sealant confining structure, e.g., side walls,gaskets, etc., disposed on one or both sides of each jaw member. Theside walls, being either rigid or flexible, may extend from the jawmember inwardly and come into contact with the body organ or tissue whenthe clamp is in a closed position. The side walls may help to confinethe sealant to the surgical site, thus preventing or minimizing thespreading of the sealant to other parts of the body.

According to one embodiment of the present disclosure, it is envisionedthat a clamp alone may be provided for clamping a body organ or tissueand for applying sealant. In this embodiment, a user places the clamparound the organ and closes the clamp. It is also envisioned that theclamp has parallel or pivotal jaw members and is designed and configuredfor use on a linear staple line. The user may then use means disposed onthe clamp or an external means to apply the biological sealant to thetissue. Means for applying biological sealant disposed on the clamp caninclude a switch, button or slide to release biological sealant fromwithin the clamp, through openings within the clamp, and onto thetissue. External means, such as a syringe, can be used to inject theclamp with a biological sealant solution that would be applied to thetissue through openings within the clamp. Side walls may be disposed onthe jaw members to confine the sealant to the desired location.

A method of the present disclosure includes the steps of placing an endeffector or clamp near an anastomosis site; closing the end effector orclamp to substantially surround the perimeter of the body organ to besealed; applying biological sealant to the anastomosis site via the endeffector or clamp; allowing time for the biological sealant to cure orpartially cure; opening the end effector or clamp; and removing theapparatus from the patient.

According to an embodiment of the present disclosure, it is envisionedthat the end effector may be configured to apply sealant to a surgicalsite that has been linearly stapled.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given aboveand the detailed description of the embodiments given below, serve toexplain the principles of the disclosure, wherein:

FIG. 1 is a perspective view of an extraluminal sealant applicator inaccordance with the present disclosure;

FIG. 2 is a perspective view of the distal portion of the end effectorof the extraluminal sealant applicator of FIG. 1 depicted in a closedposition around a body organ;

FIG. 3 is a longitudinal cross-sectional view of the end effector of theextraluminal sealant applicator of FIG. 1 depicted in a closed positionaround a body organ;

FIG. 4 is a cross-sectional view of the end effector of the extraluminalsealant applicator of FIG. 1, as taken through A-A of FIG. 1;

FIGS. 5-7 are enlarged cross-sectional views of portions of the endeffector of the extraluminal sealant applicator of FIG. 1, illustratingdifferent types of side walls;

FIGS. 8 and 9 are enlarged cross-sectional views of portions of the endeffectors of the extraluminal sealant applicator of FIG. 1, illustratingdifferent types of reservoirs within the end effector;

FIGS. 8A and 9A are plan views from the inward side of the end effectorsshown in FIGS. 8 and 9, respectively;

FIGS. 10-14 are cross-sectional views of differently shaped endeffectors which can be used with the extraluminal sealant applicator ofFIG. 1;

FIG. 15 is a cross-sectional view of a clamp-type extraluminal sealantapplicator in accordance with the present disclosure;

FIG. 16 is a perspective view of the clamp-type extraluminal sealantapplicator of FIG. 15 depicted in a closed position around a body organ;and

FIG. 17 is a perspective view of a clamp-type extraluminal sealantapplicator for use with a linear stapling device depicted in a closedposition on tissue.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed extraluminal sealant applicatorswill now be described in detail with reference to the drawing figureswherein like reference numerals identify similar or identical elements.As used herein and as is traditional, the term “distal” refers to thatportion which is farthest from the user while the term “proximal” refersto that portion which is closest to the user.

Referring initially to FIG. 1, an extraluminal sealant applicator isgenerally designated as 10. The extraluminal sealant applicator 10includes a handle member 12, a shaft 20 extending distally from thehandle member 12, and an end effector 24 operatively supported on adistal end 21 of the shaft 20. As seen in FIG. 1, the handle member 12includes end effector operating means 14, sealant-applying structure 16,and end effector locking means 18. The shaft 20 may carry one or moreconduits 22 for transporting sealant 34 (shown in FIGS. 2 and 4)therethrough. The end effector 24, as shown in FIG. 1, may be in theform of a clamp and includes a first jaw member 28 and a second jawmember 30. It is envisioned that the end effector 24 is operativelyconnected to the distal end 21 of the shaft 20 by a hinge 32 or thelike.

With continued reference to FIG. 1, the end effector operating means 14may be a slider-type device operatively associated with handle member12. In operation, as the end effector operating means 14 is slid ineither a distal or proximal direction (as indicated by arrow “A”), thejaw members 28, 30 are actuated between open and closed positions. It isenvisioned that the jaw members 28, 30 may close upon proximal movementof the end effector operating means 14 and open upon distal movement ofthe end effector operating means 14. It is also envisioned to have thejaw members 28, 30 open or close upon depression of a button, the flipof a switch, the depression of a handle or trigger, or any otherreasonable means.

As seen in FIG. 1, the sealant-applying structure 16 may be in the formof a trigger operatively supported on the handle member 12. It isenvisioned that in operation, depression of the trigger 16 pushessealant 34 (shown in FIGS. 2 and 4), e.g., biological sealant, throughthe conduit 22 in the shaft 20 towards the end effector 24. It iscontemplated to use a slider device, button, switch or any otherreasonable means to dispense sealant 34 through the conduit 22 of theshaft 20 and towards the end effector 24. In an embodiment, sealant 34may be introduced into the end effector 24 by an external means 200,such as, for example, by injection with a syringe (FIG. 16). The sealant34 may be released from a reservoir (not shown) in or on the handlemember 12. It is envisioned that the trigger 16 may cause the sealant 34to be sprayed out of the end effector 24 on the distal end 21 of theshaft 20 onto a staple line or target tissue.

It is contemplated that the sealant 34 is any material for joining,healing, sealing or otherwise treating tissue. In an embodiment, thesealant 34 is a bio-compatible sealant and/or adhesive, including, andnot limited, to sealants which cure upon tissue contact, sealants whichcure upon exposure to ultraviolet (UV) light, sealants which aretwo-part systems which are kept isolated from one another and arecombined or any combinations thereof. In one embodiment, it iscontemplated that such sealants and/or adhesives are curable. Forexample, the sealants and/or adhesives may have a cure time of fromabout 10 to about 15 seconds may be used. In another embodiment, it iscontemplated that a sealant 34 and/or adhesive having a cure time ofabout 30 seconds may be used. In some embodiments, the sealant 34 and/oradhesive is a bioabsorbable and/or bio-resorbable material.

In certain embodiments, the sealant 34 is a PEG-based material. Examplesof classes of materials useful as the sealant 34 and/or adhesive includeacrylate or methacrylate functional hydrogels in the presence of abiocompatible photoinitiator, alkyl-cyanoacrylates, isocyanatefunctional macromers with or without amine functional macromers,succinimidyl ester functional macromers with amine or sulfhydrylfunctional macromers, epoxy functional macromers with amine functionalmacromers, mixtures of proteins or polypeptides in the presence ofaldehyde crosslinkers, Genipin, or water-soluble carbodiimides, anionicpolysaccharides in the presence of polyvalent cations, etc. Examples ofsealants, which can be employed, include fibrin sealants andcollagen-based and synthetic polymer-based tissue sealants. Examples ofcommercially available sealants are synthetic polyethylene glycol-based,hydrogel materials sold under the trade designation CoSeal™ by CohesionTechnologies and Baxter International, Inc.

Surgical biocompatible sealants 34 which may be used in accordance withthe present disclosure include adhesives whose function is to attach orhold organs, tissues or structures. Examples of adhesives which can beemployed include protein derived, aldehyde-based adhesive materials, forexample, the commercially available albumin/glutaraldehyde materialssold under the trade designation BioGlue™ by Cryolife, Inc., andcyanoacrylate-based materials sold under the trade designationsIndermil™ and Derma Bond™ by Tyco Healthcare Group, LP and EthiconEndosurgery, Inc., respectively.

Some specific materials which may be utilized as adhesives includeisocyanate terminated hydrophilic urethane prepolymers derived fromorganic polyisocyanates and oxyethylene-based diols or polyols,including those disclosed in U.S. Pat. Nos. 6,702,731 and 6,296,607 andU.S. Published Patent Application No. 2004/0068078; alpha-cyanoacrylatebased adhesives including those disclosed in U.S. Pat. No. 6,565,840;alkyl ester based cyanoacrylate adhesives including those disclosed inU.S. Pat. No. 6,620,846; adhesives based on biocompatible crosslinkedpolymers formed from water soluble precursors having electrophilic andnucleophilic groups capable of reacting and crosslinking in situ,including those disclosed in U.S. Pat. No. 6,566,406; two part adhesivesystems including those based upon polyalkylene oxide backbonessubstituted with one or more isocyanate groups in combination withbioabsorbable diamine compounds, or polyalkylene oxide backbonessubstituted with one or more amine groups in combination withbioabsorbable diisoycanate compounds as disclosed in U.S. PublishedPatent Application No. 2003/0032734, the entire contents of which areincorporated by reference herein; and isocyanate terminated hydrophilicurethane prepolymers derived from aromatic diisocyanates and polyols asdisclosed in U.S. Published Patent Application No. 2004/0115229, theentire contents of which are incorporated by reference herein. It iscontemplated that any known suitable adhesive may be used.

In certain embodiments, the sealant 34 includes hemostats whose functionit is to halt or prevent bleeding. Examples of hemostat materials, whichcan be employed, include fibrin-based, collagen-based, oxidizedregenerated cellulose-based and gelatin-based topical hemostats.Examples of commercially available hemostat materials arefibrinogen-thrombin combination materials sold under the tradedesignations CoStasis™ by Tyco Healthcare Group, LP, and Tisseel™ soldby Baxter International, Inc. Hemostats herein include astringents,e.g., aluminum sulfate, and coagulants.

It is envisioned that sealants 34 may be a relatively low viscosityfluid or liquid such that the sealant 34 may freely flow. It is furtherenvisioned that the sealant 34 may include a fine powder of particulatematerial.

In other embodiments, sealants 34 may include a medicament. Themedicament may include one or more medically and/or surgically usefulsubstances such as drugs, enzymes, growth factors, peptides, proteins,dyes, diagnostic agents or hemostasis agents, monoclonal antibodies, orany other pharmaceutical used in the prevention of stenosis.

Sealant 34 may include visco-elastic film forming materials,cross-linking reactive agents, and energy curable adhesives. It isenvisioned that an adhesive may be cured with the application of waterand/or glycerin thereto. In this manner, the water and/or glycerin curethe adhesive and hydrate the wound.

It is further contemplated that the sealant 34 may include, for example,compositions and/or compounds which accelerate or beneficially modifythe healing process when particles of the composition and/or compoundare applied to or exposed to a surgical repair site. For example, thesealant 34 may be a therapeutic agent which will be deposited at therepair site. The therapeutic agent can be chosen for its antimicrobialproperties, capability for promoting repair or reconstruction and/or newtissue growth. Antimicrobial agents such as broad spectrum antibiotic(gentamycin sulfate, erythromycin or derivatized glycopeptides) whichare slowly released into the tissue can be applied in this manner to aidin combating clinical and sub-clinical infections in a tissue repairsite. To promote repair and/or tissue growth, sealant 34 may include oneor several growth promoting factors, e.g., fibroblast growth factor,bone growth factor, epidermal growth factor, platelet derived growthfactor, macrophage derived growth factor, alveolar derived growthfactor, monocyte derived growth factor, magainin, and so forth. Sometherapeutic indications are: glycerol with tissue or kidney plasminogenactivator to cause thrombosis, superoxide dimutase to scavenge tissuedamaging free radicals, tumor necrosis factor for cancer therapy orcolony stimulating factor and interferon, interleukin-2 or otherlymphokine to enhance the immune system.

The end effector locking means 18 is depicted in FIG. 1 as a button thatcan be depressed for locking the end effector 24 in the closed position.It is contemplated by this disclosure that the end effector 24 isspring-biased to an open position. Accordingly, in use, once the endeffector 24 is actuated to a closed position (shown as phantom lines inFIG. 1), the user can activate the locking means 18 to maintain the endeffector 24 in the closed position. While the locking means 18 isdepicted as a button on the handle member 12, it is envisioned that thelocking means 18 can also be, for example, a lever, slider device orincorporated into the end effector operating means 14 as a ratchet-typetrigger. It is also envisioned that a locking means 18 can be disposedon the distal end of each jaw member 28, 30 (shown in FIG. 2) such thatthe two locking means 18 engage each other when the end effector 24 isin a closed position. The different types of locking, means 18envisioned by this present disclosure may be used individually or inconjunction with each other.

As seen in FIG. 1, the conduit 22 of the shaft 20 is shown as a singlelumen or channel. It is contemplated that multiple conduits 22 can bedisposed in the shaft 20. In an embodiment, two channels may be disposedin the shaft 20, wherein each conduit 22 supplies each of the two jawmembers 28, 30 with sealant 34. Each of the two conduits 22 disposed inthe shaft 20, can also be used for carrying one part of a two-partsealant, such that the two parts of the sealant mix with each other toform a sealant 34 prior to coming into contact with the body organ 36 ortissue (FIG. 2) or as they are dispensed from the jaw members 28, 30. Itis also contemplated that four conduits 22 are disposed in the shaft 20,wherein two conduits 22 supply each jaw member 28, 30. As such, eachpart of a two-part sealant may be supplied to each of the two jawmembers 28, 30. It is also contemplated to have any or all of theconduits 22 disposed on or along an external portion of the shaft 20,rather than inside the shaft 20.

Turning now to FIGS. 2-4, the end effector 24 of the extraluminalsealant applicator 10 is shown closed around a body organ 36. Forexample, the body organ 36 may be a bronchus, bowel, intestine, etc. orany other part of the body that has been joined by linear stapling (FIG.17). As seen in FIGS. 2-4, the body organ 36 is depicted after astapling procedure using an end-to-end anastomosis stapler has takenplace. During such a procedure, surgical staples 38 are commonly used tojoin two sections of the body organ 36.

As seen in FIGS. 3 and 4, a layer of sealant 34 has been dispensedbetween the end effector 24 and the body organ 36. Sealant 34 at leastsubstantially surrounds, preferably completely surrounds, the perimeterof the body organ 36 and seals any holes or tears (not shown) created byeach surgical staple 38, any gaps that might exist between adjacentsurgical staples 38, and the junction between the adjacent tissues tostrengthen the bond therebetween.

As seen in FIGS. 2 and 3, the jaw members 28, 30 are depicted in aclosed position around the body organ 36 and are locked together vialocking means 18.

As seen in FIG. 4, a pair of sealant confining structures, e.g., sidewalls 40, is provided on or extends from both sides of each jaw member28, 30 and extends the length thereof. The side walls 40 are configuredand adapted to retain sealant 34 in close proximity to and overlyingsurgical staples 38 in order to keep sealant 34 from spreading away fromthe row of surgical staples 38. A first end 40 a of each side wall 40 isoperatively connected to each jaw member 28, 30, and a second end 40 bof each side wall extends radially inwardly such that the second end 40b of the side wall 40 makes contact with the body organ 36 when the endeffector 24 is in the closed position.

It is within the scope of the present disclosure for the side walls 40of the end effector 24 to be made from either a rigid material (FIGS. 5and 6), a flexible material (FIG. 7), or some combination thereof. As isto be appreciated, the side walls 40, which are flexible, substantiallyconform to the contours of the body organ 36. It is envisioned that thesecond end 40 b of the side walls 40 may contain friction increasingelements 44 to increase friction between the second end 40 b of the sidewall 40 and the body organ 36, as illustrated in FIGS. 5 and 6. It isenvisioned that such friction increasing elements 44 can be a series adetents (see FIG. 5), one or more pins (see FIG. 6), any combinationthereof, or any other reasonable means to increase friction between thesecond end 40 b of the side wall 40 and the body organ 36. Frictionincreasing elements 44 may help maintain the end effector 24 in placewhen in contact with the body organ 36.

Referring again to FIG. 4, at least one reservoir 42 is formed in eachjaw member 28, 30 for holding and/or dispensing sealant 34 to the targettissue site. Reservoir 42 may be in the form of a channel extending atleast partially around or along the jaw members 28, 30. The reservoir 42is in fluid communication with the conduit 22 for receiving the sealant34 therefrom. As seen in FIG. 4, the sealant 34 has been released ordispensed from the reservoir 42, substantially surrounds the body organ36 and substantially covers the surgical site and the surgical staples38 located therearound. The side walls 40 of the jaw members 28, 30 mayhelp confine sealant 34 to the target tissue site. The end effector 24is removed from the body organ 36 once the sealant 34 has fully orpartially cured.

It is envisioned that the shape of the reservoir 42 is such that the endeffector 24 and the jaw members 28, 30 thereof are able to be freelyreleased from the body organ 36 even if the sealant 34 fully cures orpartially cures while still completely or partially filling thereservoir 42. It is also envisioned that prior to the dispensing of thesealant 34 from the jaw members 28, 30, a lubricant (not shown) isapplied to the reservoir 42 and/or the inwardly facing surfaces of thejaw members 28, 30 to prevent fully or partially cured sealant 34 fromsticking to such surfaces.

It is envisioned by the present disclosure to have a series ofindividual reservoirs 42 a (see FIGS. 8 and 8A) to be provided along thelength of each jaw member 28, 30 and/or, as mentioned above, oneelongate reservoir 42 b that extends the full length or a portion of thelength of the jaw members 28, 30 (see FIGS. 9 and 9A).

It is also envisioned that the apparatus of the present disclosurecontains one reservoir 42 disposed towards the proximal portion of eachjaw member 28, 30 (not shown). In such an embodiment, a bead of sealant34 will contact or come close to contacting the proximal portion of thebody organ 36 when the end effector 24 is in an open position. When theend effector 24 is moved towards a closed position, each of the jawmembers 28, 30 will push/distribute the sealant 34 over the surface ofthe body organ 36 as the jaw members 28, 30 gradually come into contactwith more surface area of the body organ 36.

It is also envisioned that an external means 200 (see FIG. 16) can beused to supply the sealant 34 to the body organ 36 via the end effector24. The external means 200, such as a syringe, can be used to inject thejaw members 28, 30 with sealant 34 that would be distributed and/ordispensed to the body organ 36 through openings within the jaw members28, 30.

It is further envisioned that each of the two jaw members 28, 30 canreleasably hold a reinforcing pledget (not shown) that is impregnatedwith sealant. In such an embodiment, each jaw member 28, 30 would have asealant-impregnated pledget (not shown) disposed thereon. When the jawmembers 28, 30 move into a closed position, the pledgets may contact andadhere to the staple line (removing itself from the jaw members 28, 30),thus sealing the site with sealant 34.

Turning now to FIGS. 10-12, different embodiments of the jaw members 28,30 are shown and will be described. FIG. 10 shows an end effector 24 aincluding a rigid, arcuate pair of jaw members 28 a, 30 a. These may beused when the body organ 36 does not significantly deform when pressureis asserted thereto. FIG. 11 depicts an end effector 24 b including arigid, planar pair of jaw members 28 b, 30 b. This pair may be used whenthe body organ 36 deforms to a somewhat flattened shape due to thepressure from the stapling surgery or from the pressure associated withthe closing of the jaw members 28 b, 30 b. FIG. 12 illustrates an endeffector 24 c including a deformable pair of jaw members 28 c, 30 c.These clamps may be used when the body organ 36 deforms in shape whensubjected to the pressure from the surgery and/or the closing of jawmembers 28 c, 30 c. Jaw members 28 c, 30 c are designed and configuredto conform or essentially conform to the resulting curvature that thebody organ 36 takes from the pressure of the surgery and/or the pressureof the jaw members 28 c, 30 c themselves. Surgeons will be able todetermine which set of jaw members 28, 30 to use either by pastexperiences or by trial and error.

As seen in FIGS. 13 and 14, it is also envisioned for the jaw members28, 30 to be configured for linear stapling. FIG. 13 depicts the jawmembers 28, 30 pivotally attached to the shaft 20 for clamping tissuetherebetween. FIG. 14 depicts the jaw members 28, 30 operativelyattached to the shaft 20 in a parallel manner for clamping tissuetherebetween. These embodiments can be used to apply sealant 34 totissue that has been joined by linear stapling.

Turning now to FIGS. 15-17, an embodiment of an extraluminal sealantapplicator in accordance with an embodiment of the present disclosure isgenerally designated as 110 and is referred to as an applicator clamp.Applicator clamp 110 includes a pair of jaw members 128, 130 connectedby a hinge 132. Each jaw member 128, 130 contains at least one port 142for holding and/or distributing sealant 34 to the staple line 146 andalso contains side walls (similar to the side walls 40 of jaw members28, 30) to help reduce the lateral spread of sealant 34 that has beendispensed. It is envisioned that a locking device 118 can be provided oneach of the jaw members 128, 130, opposite the hinge 132 to keep theapplicator clamp 110 from opening unintentionally.

The applicator clamp 110 is placed around or adjacent the staple line146 of body organ 136 and is clamped in a closed position thereto. Oncein place, the user distributes sealant 34 to the staple line 146 byactivating a sealant applicator device 144 (e.g., a push bulb) disposedon the jaw members 128, 130 or by an external means 200, such as asyringe, as discussed above and illustrated in FIG. 16. After thesealant 34 has been dispensed, the user waits for the sealant 34 tofully or partially cure before removing the applicator clamp 110.

A method of the present disclosure, using any of the apparatus disclosedhereinabove, may be implemented after an anastomosis procedure where abody organ, such as an intestine, bronchus or bowel, is surgicallystapled using an end-to-end anastomosis stapler or other suitabledevice. After such a procedure, the end effector 24 of the apparatus 10is positioned near the staple line of the tissue, with the end effector24 in an open position. The user then closes the end effector 24 aroundthe body organ 36 by actuating the end effector operating means 14 ofthe apparatus 10. After the end effector 24 is closed, the user appliesthe sealant 34 to the desired tissue by actuating the sealant-applyingstructure 16. Once the sealant 34 is applied to the tissue, the endeffector 24 is maintained in a closed position until the sealant 34 hassufficiently cured. After sufficient curing has taken place, the usermay open the end effector 24 by actuating operating means 14 andremoving the apparatus 10 from the patient's body.

According to one embodiment of the present disclosure, it is envisionedthat an applicator clamp 110 may be provided for surrounding a bodyorgan 136 or tissue and for applying sealant 34 thereto. In thisembodiment, a user places the applicator clamp 110 around the body organ136 and closes the applicator clamp 110. The user then may use a sealantapplicator device 144 and/or an external means 200 to apply the sealant34 to the tissue. The sealant applicator device 144 disposed on theapplicator clamp 110 can include a switch, button, slide or the like torelease biological sealant from within the applicator clamp 110, throughopenings within the applicator clamp 110, and onto the tissue. Externalmeans 200, such as a syringe, can be used to inject the applicator clamp110 with a biological sealant solution that would be applied to thetissue through openings within the applicator clamp 110. Side walls maybe disposed on the jaw members 128, 130 to confine the sealant 34 to thedesired location.

According to an embodiment of the present disclosure, it is envisionedthat the end effector 24 may be configured to apply sealant 34 to asurgical site that has been linearly stapled.

It is to be appreciated that the extraluminal sealant applicators andmethod of the present disclosure may be utilized in a number of otherapplications and is not limited solely to bowel, intestine or bronchusanastomosis.

While several particular forms of the extraluminal sealant applicatorshave been illustrated and described, it will also be apparent thatvarious modifications can be made without departing form the spirit andscope of the present disclosure. For example, it is envisioned andwithin the scope of the present disclosure for a sensor to detect whenthe sealant has sufficiently cured, and thus when the surgeon shouldremove the apparatus. It is also envisioned and within the scope of thepresent disclosure for pins disposed on the edges of the side wallspenetrate the outer skin of the body organ, but do not penetrate beyondthe outer skin. It is still further envisioned and within the scope ofthe present disclosure that an adhesive can be applied to theanastomosis site, in lieu of, or in addition to the sealant.

It is further contemplated that each of the extraluminal sealantapplicators described herein may be used following surgery performedwith an annular surgical anastomosing device, which is capable ofapproximating, adhering and cutting tissue.

Thus, it should be understood that various changes in form, detail andapplication of the extraluminal sealant applicators and method of thepresent disclosure may be made without departing form the spirit andscope of the present disclosure.

1-27. (canceled)
 28. A method of performing an anastomosis of two holloworgans, comprising: providing an applicator including an end effectorhaving two jaw members defining an open circle in a closed position andhaving tissue-contacting surfaces and dispensing apertures directedradially inwardly, and at least one conduit configured for conveying amaterial to the apertures; positioning the jaw members around a junctionbetween the two hollow organs; approximating the jaws of the endeffector to substantially surround the junction; and applying thematerial to the junction between the two luminal organs via the endeffector.
 29. The method according to claim 28, wherein the material isselected from the group consisting of a sealant and an adhesive.
 30. Themethod according to claim 29, wherein the material comprising a firstmaterial and a second material, the first material and second materialforming a two part adhesive.
 31. The method according to claim 28,further comprising the step of stapling the organs.
 32. The methodaccording to claim 28, further comprising disposing the material inreservoir, the reservoir being in communication with the apertures. 33.The method according to claim 28, wherein approximating includes movingthe handle member from a neutral position to an actuated position 34.The method according to claim 33, wherein when the handle member movesfrom the neutral position to the actuated position, the material ispushed from a reservoir through a shaft and dispensed from theapertures.